Dural arteriovenous fistula

Second Round of Late-Breaking Clinical Trial Results Announced at VIVA23

Retrieved on: 
Tuesday, October 31, 2023

Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.

Key Points: 
  • Below are highlights of this afternoon's 3 late-breaking clinical trial presentations.
  • Results from Abbott's LIFE-BTK randomized clinical trial (RCT) demonstrate that Esprit BTK (Abbott) reduces disease progression and helps improve medical outcomes compared to balloon angioplasty, the current state of care.
  • In the LIFE-BTK trial, wound assessment was not a prespecified powered primary or secondary endpoint but rather a prespecified descriptive endpoint.
  • The trial offers the largest ischemic wound data set to date, collected systematically and adjudicated independently in a blinded fashion.

Continued Clinical Success Reported with Unique Cutting-Edge Vessel Prep Device

Retrieved on: 
Thursday, June 30, 2022

PARK CITY, Utah, June 30, 2022 /PRNewswire/ -- Transit Scientific shares successful outcomes on multiple fistula and graft cases using its XO Score Sheath Platform along with off-the-shelf percutaneous transluminal angioplasty (PTA) balloons.

Key Points: 
  • First-of-its-kindmetal-alloy scoring, cutting, and constraining structure (CS) device continues to elevate angioplasty treatment of chronic dialysis fistulas and grafts.
  • The lesion was resistant to initial treatment using a high-pressure PTA inflated to 40 atmospheres (ATM).
  • The lesion was then treated with the XO Scoredevice and followed by effacement of the stenosis with standard balloon PTA inflated to nominal pressure (9ATM).
  • When the angioplasty balloon is inflated, the struts/grooves expand with the balloon and rotate 90 to apply focal force to the vessel.

MCRA Expands Neurology Division into Neurointerventional Market

Retrieved on: 
Wednesday, September 22, 2021

Herrmann also had significant interactions onapplications for the clinical use ofdrug and biologic baseddevice combination products during his time with the agency.

Key Points: 
  • Herrmann also had significant interactions onapplications for the clinical use ofdrug and biologic baseddevice combination products during his time with the agency.
  • Dr. Herrmann said "I am very excited to join the highly distinguished team at MCRA and expand their regulatory expertise in the area of neurointerventional devices.
  • About MCRA, LLC:MCRA is the leading privately held independent medical device and biologics Clinical Research Organization (CRO) and advisory firm.
  • MCRA has offices in Washington, DC, Hartford, CT, and New York, NY, and serves more than 700 clients globally.